The effect of bosentan, a selective endothelin antagonist, on cardiovascular performance in patients with a Fontan circulation - Bosentan therapy in Fontans

Phase 1

• Conditions: Patients with a Fontan circulation (that is they have had a Fontan operation for a functionally univentricular heart); MedDRA version: 9.1 Level: LLT Classification code 10045545 Term: Univentricular heart; MedDRA version: 9.1 Level: LLT Classification code 10065950 Term: Cavopulmonary anastomosis; MedDRA version: 9.1 Level: LLT Classification code 10037456 Term: Pulmonary vascular resistance abnormality

• Registration Number: EUCTR2005-005898-29-GB
• Lead Sponsor: niversity Hospital Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-09
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

Age 18 or over with a Fontan circulation and NYHA II or greater symptoms of heart failure.
The patient has no other significant illness that would preclude them from completing the study.
Patients must be available to complete follow up.
Patients must be able to provide informed consent.
Patients must agree not to become pregnant during the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Lack of sinus rhythm at enrolment
Permanent pacemaker in situ
Inability to complete exercise testing
Pre-existent liver disease as described in the bosentan SmPC1
Significant haematogical abnormality or renal dysfunction.
Current use of any prostanoid, other endothelion receptor antagonist or pulmonary vasodilator therapy, such as PDE V inhibitors i.e. sildenafil or similar.
Pregnancy
Current enrolment in a clinical trial
Any contraindication according to the bosentan SmPC1

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified